MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 11MM STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Inflammation (1932); Pain (1994)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 115370 comp rvs tray 987730; xl-115363 hmrl brng 083700; 115310 comp rvrs shldr glnsp 036770; 115330 comp rvrs shdr glen bsplt 550170; 118001 comp ti std taper 022770; 180553 comp lk scr 3.5hex 586200; 180509 comp non-lckng screw 931620; 180503 comp locking screw 120540; 180503 comp locking screw 424160; 115382 comp rvs cntrl scr 714480.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02436, 0001825034 - 2021 - 02437, 0001825034 - 2021 - 02438, 0001825034 - 2021 - 02439, 0001825034 - 2021 - 02441, 0001825034 - 2021 - 02442, 0001825034 - 2021 - 02443, 0001825034 - 2021 - 02444, 0001825034 - 2021 - 02445, 0001825034 - 2021 - 02446.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left total shoulder arthroplasty revision procedure approximately six(6) years post-implantation due to pain, loss of range of motion, and loosening of the components.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent a revision procedure due to an axillary cyst that was found that communicated to bone/joint.All hardware was removed.Irrigation and debridement of joint space and cyst with cement spacer & drains were placed.During the procedure surgeon had difficulty removing 2 stripped screws, but were explanted without indication of retained products.

• Brand Name: COMP PRIMARY STEM 11MM STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12369963
• MDR Text Key: 268214218
• Report Number: 0001825034-2021-02440
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 113651
• Device Lot Number: 658090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention